Computer-Generated Quality of Life Assessment Program for Advanced Non-Small Cell Lung Cancer Patients (LUNL2)

Study Design The study will be conducted using an unblinded, randomized trial design. Patients starting systemic therapy for advanced NSCLC will be invited to complete the LCSS-QL upon starting first-line systemic chemotherapy and then prior to subsequent treatment visits (every 3 weeks). Patients will then be randomized at baseline to whether or not their physician will receive this information at the time of clinic visits for the duration of study participation. Randomization codes will be generated by computer program, with stratification by physician, platinum-based versus non-platinum based therapy and Eastern Cooperative Group Performance Status 0 and 1 versus 2 and 3. All patients complete the LCSS-QL at baseline, at the beginning of each cycle of chemotherapy, and at follow up visits until disease progression (initiation of subsequent therapy)or discontinue clinic visits an expected average of 12 to 18 weeks.

Patient Population All NSCLC patients with advanced disease (Stage 3B or 4) starting systemic therapy at the Princess Margaret Hospital will be eligible to participate. Inclusion criteria include the physical ability to use the hand-held instrument (adequate vision, manual dexterity), provision of written informed consent, and written fluency in English, French, Italian, Spanish, Portuguese or Chinese. Patients will be excluded if they are unable to complete or understand the assessment process, or if they are receiving concurrent radical radiotherapy.

Physician Information Physicians will be trained in interpretation of the LCSS electronic output data, in order to facilitate interpretation of the different domains of patient well-being, for example pain scores. An endorsement sheet will be printed in addition to the LCSS data, highlighting major changes in quality of life. For example, deterioration in pain control will be highlighted with suggestions to increase or change pain medication, consider radiotherapy and other pain management options, including changing systemic therapy.

Outcomes

Endpoints include palliative care referral rates, duration of systemic therapy, use of supportive interventions and QoL during treatment.

Data on the number of chemotherapy cycles administered, referral to palliative care (including timing), institution of additional supportive treatments, and number of imaging tests ordered will be collected for all patients prospectively. Data on LCSS scores, subsequent therapy, and date of death will also be recorded.

Inclusion criteria

• Diagnosis of Primary Non Small Cell Lung Cancer
• Stage 3 or 4 Lung Cancer
• To receive 1st line Chemotherapy
• Platinum based chemotherapy or Non Platinum
• Physical ability to use the hand held device(adequate vision, manual dexterity),
• ECOG 1-2
• Written fluency in English, French, Italian, Spanish, Portuguese or Chinese

Exclusion criteria

• Patients will be excluded if they are unable to complete or understand the assessment process,
• If they are receiving concurrent radical radiotherapy.